Monthly Archives: April 2013

“How am I going to explain this to the Board?” Rupert moaned as he thumped his head on the desk. Across from him sat corporate lawyer Sosumi Ciyuencourt and the Vice President of Manufacturing Stirrin Cooquet.

“Tell them that we will soon be manufacturing our own HoriXentalBop in June,” Stirrin said. “But in the meantime, we rely on Glaxo, and they get it from some contract manufacturer. If we can’t trust a Big Pharma manufacturer, who can we trust? It turns out they have ‘issues.’ Their product is delayed, so there is no treatment of Restless Third Leg Syndrome available until at least June.” [1]

“That’s ‘Representative,’ Rupert,” Sosumi said. “There’s no point in namecalling.”

“After their pathetic showing on gun control, of course there’s a point in namecalling,” Rupert said. “They have no intention of representing us, but we need to jump to their command?”

“Congress is one of our biggest single customers for HoriXentalBop,” Stirrin said. “No one suffers from Restless Third Leg Syndrome like a Congressman.”

“What about Mark Sanford?” Rupert asked. “He’s not in Congress and he’s suffering more than anyone else I know.” [2]

“Yes, that’s why he’s trying to get elected in the worst way,” Sosumi said. “If he gets elected in that worst way, he can wallow with his fellow suffers.”

“Then there’s Anthony Weiner,” Stirrin said with an almost-straight face. “His case is so bad that he sexted his namesake on Twitter.”

Sosumi cleared her throat noisily. “This is no laughing matter. Congress acted decisively for the first time in years, ensuring there is no airline delay of their drug supply. Now it’s up to us now that Big Pharma has failed us.”

Rupert looked directly into Stirrin’s eyes. “Now it’s up to you, Stirrin. I see I’m late for my next meeting. So get going before Congress does us any more favors.”

“Hold on, let me write that down.” Rupert clutched the phone between his shoulder and cheek, then leaned across his desk to grab a memo pad and a pen. “OK, go ahead.” A voice spoke in his ear and he scribbled. “Got it, thanks.” He terminated the call and looked at his note. “Thursday at seven,” he mumbled and wrote on his desk calendar.

Then he looked back at the print on the memo pad. It read, ‘Qality Matters!’ Underneath, in smaller letters, was ‘Tip #233: Qualaty problems? Try rearranging your Executive Teem!’ Along the bottom of the pad in small letters was ‘Nebraka is for louvers’ [1]

He punched a speed dial button and asked, “Tricia, where did we get these memo pads?”

The voice of Tricia answered, “Someone I know got a ton of them from Novartis for free. I think they had lots of layoffs at the plant and didn’t want the pads any more.”

“Novartis had layoffs?” Rupert asked. “Why?”

“Quality issues, that’s all I know. I thought all you execs keep track of pharma industry goings-on. I sure don’t.”

Rupert hung up, turned to his computer, and googled ‘Novartis quality.’ This led to several hits including a Forbes article about manufacturing gaffes. Panicked, he dug through the Cappuccino Pharmaceuticals directory to find a quality department. His fingers danced on the phone’s touchpad and made several mistakes before he dialed correctly. Finally a voice announced he had reached Quality Control.

“Hello, this is Rupert. Get me the head of Quality Control,” he said.

“Rupert? Who the heck is Rupert?”

“I’m your CEO, who are you?” Rupert began to sweat.

“My CEO?” the voice said. “I’m a contract employee from Temp-O-Lab, my CEO is someone named Jane.” The voice paused. “Here, you should talk to Mr. Caldez.”

“This is James Caldez, may I help you?” a new voice said.

“This is Rupert Madasheck. How good is the quality at Cappuccino?” Rupert asked. “Are we square with the FDA and all that?”

There was a long pause. Finally the voice asked, “You’re the CEO? You realize this is Quality Control, right? You might want another department.”

“If I want to know about quality around here, of course I want Quality Control,” Rupert said. “Don’t I?” He realized that was a bad question. Never show fear or indecision, he thought. Show clear, direct leadership no matter what. Too late.

Rupert’s hands shook violently. “Alright, thanks,” he said and hung up. He quickly dialed the Legal Department and asked Sosumi Ciyuencourt, “Are we being sued for anything? Anything like kickback schemes?”

Sosumi spoke after a brief pause. “No. I do not believe we are being sued for anything of consequence at the moment. Why do you ask? We weren’t giving rebates to pharmacies if they switch patients to our drugs, were we?” [2]

That night he dreamt of being stuck in a Dilbert comic with ‘Qality Matters!’ memo pads dancing around him. [3] It was the same nightmare he suffered for the last 23 years or more. Will it never end?

“Marketing, get in here,” Rupert shouted into the phone.

A minute later, Malisma Collins strode into his office with her eyes flashing. “You can learn my name,” she said. “I’ve been here for seven years. You don’t need to learn a new name like your R&D revoloving door.”

Rupert looked down at his flash cards. “Malisma. I do know your name. So there.” He glanced at his computer screen and said, “Could you please explain the name for this new malaria vaccine we just licensed form UCSD? Who decided to name it EDS?”

Malisma studied her fingernails closely. “It was named by the post-doctoral student in charge. I understand it stands for ‘Eat Death Scum,’ so we needed a different name.”

“Eat death scum?” Rupert asked. “Where would anyone get a name like that, Malaria?”

“Malisma. My name is Malisma. Learn it.” She inhaled deeply. “Remember, we are asking people to eat this algae. Pond scum, really. It’s been engineered to deliver proteins from malaria and cholera.”

Rupert choked. “Cholera? Are you planning to have patients eat death – oh, I see.”

“Yes. We can’t vaccinate everyone in the poorest parts of the world, places where malaria is rampant. We can’t even be sure they will take pills. But we can send food that will help raise antibodies against the worst diseases.”

“Excellent!” Rupert leaned back in his chair. “We can finally cure the world of its problems. Us, tiny Cappuccino Pharmaceuticals.” He sat up. “So does this, um, this Eat Death Scum, this pond scum. Does it work?”

Malisma looked carefully at her toenails with their tiny encrusted diamonds. “Well, not yet. Corrina, the R&D person in charge, said they raise antibodies in the gut where you’d expect. But mosquitoes bite and hit the bloodstream. That means we need to inject the proteins into people.”

Rupert glared angrily. “Didn’t you just say you can’t vaccinate everyone? Isn’t that about two billion people?”

Malisma noticed how incredibly perpendicular the walls were. And how close, and getting closer. “Um, yes. So for the moment EDS doesn’t actually work.”

“How could we possibly make such a guarantee?” Calligrafa Corbin asked. “We are an excellent clinical research organization with a stellar track record.”

“I am sure you are,” said Rupert. “And so was Hoptuit or whatever they’re called. Until it wasn’t. All it took was one rogue technician who fabricated data.” [1]

Calligrafa paled. “I suppose someone had to be the first one prosecuted under the Good Laboratory Practice Regulations. We do not intend to be the second.”

Rupert frowned and swiveled in his chair. He glanced at the walls, at the ceiling tiles, at the untouched bagels and coffee in the corner. He could not look Calligrafa in the eyes. “That’s what worries me. You might settle for third. Second place might go to a company so bad that it finally went out of business overnight.”

Calligrafa began to tremble. “Oh. You mean PRACS?”

“I mean PRACS. That’s just a renamed Cetero, the lab flagged by the FDA as generating fraudulent results. [2] What gets me is that when PRACS disappeared, they wiped out maybe 40 studies. Those were run for the big boys. You know, Merck, Glaxo, Gilead, Ranbaxy. Much larger than we are. We can’t afford a fraudulent clinical trial.”

Calligrafa let go of her pen so it would stop tapping frantically. It skittered across the table and escaped to the floor.

Rupert leaned back in the soft leather chair and gazed at the ceiling. “I hate being the bad guy, but it seems Eisai has the right idea. They appointed an enforcer, someone whose job it is to make sure that Phase III trials do not fail. This enforcer will reach into the CRO actually running the trial.” [3] He sat up and forced himself to stare at Calligrafa. “So will we. We don’t like failure either. For any reason. Not during the trial, and not after.”

Calligrafa gulped and jammed her hands together.

Rupert swiveled to stare out the window of the conference room. “I do not intend to end up showing preposterous so-called data that show our superdrug for muscular dystrophy is no better than placebo. I don’t intend to dress up the statistics just to fool the rubes.” [4]

“That puts us in an impossible position,” Calligrafa said. “You want all of your drug trials to succeed but you of course want no fraud. We can fight fraud with the strictest enforcement, but how can we guarantee every trial succeeds?”

“Well, there’s that,” Rupert said. “Oh, look at the time. I really must run. We will speak further of this.” He stood up and strode out of the room.

~~~~~~~~~~~

That evening at the charity ball, Betty Lidalot felt a tingling sensation that alerted her to an approaching threat. She whirled away from a very surprised movie star in mid-sentence to face Rupert still three feet away. When she saw his shocked expression, she carefully lowered her karate stance.

“Rupert, so good to see you,” she said. “My new SpiderSense gown, do you like it? I had it made specially by Victor Mateevitsi.”

“Mateevitsi. He’s an engineer so I hooked him up with the finest fashion talent. Now women can sense approaching danger as well as Spiderman can.”

“But Spiderman is a fictitious character. He senses danger only when the author tells him to.”

“Rupert, you are such a bore. Now can you tell me how the CRO meeting went?”

Rupert’s face brightened. “It went very well. I had them sweating and quaking in their shoes. You would have been proud of me! We don’t need any fraudulent results discovered after our drugs are on the market.”

Betty’s smiled and held up her wineglass. “That’s wonderful news! So there will be no more failed clinical trials?”

Rupert picked at something in his eye. “Um, yes. About that. Well, I really must be going. Way past my bedtime.”

“Rupert Madasheck, what is this all about?” Betty hissed. Several ballroom dancers skirted away to clear a space around them.

“This is the most dismal sales report I have seen in this company,” Rupert declared to the Board of Directors. “How about if I fire the sales force, the whole lot of ‘em? Let’s move into digital marketing exclusively.”

“I understand Eli Lilly is doing something like that,” said CFO George Contenumbaes. [1] “I can let you know the annual cost savings.”

Rupert read the next item on the Board meeting’s docket, a report that lab scientist Dr. Erin Q. Stewpydde was found reporting good results on mice that didn’t even exist. [2]

“Our entire FrankNFrzerol program is shut down since its premise was based on data from non-existent mice,” Mantissa Polatis said.

“What? How could you let that happen?” Rupert roared, frothing at the mouth and suddenly towering over the cringing woman. “You’re the Vice President of Research! Can’t you control your department?”

“But I’ve only been here for three days,” Mantissa said as she shivered in her chair.

“Oh. Still, plenty of time to find the problems and shift the blame,” Rupert said as he glanced around and sat down. “Yes, and where did you find these non-existent mice?”

“That’s the problem, they never existed,” Mantissa said. “No such mice were ever protected from saturated fatty acid-induced atherosclerosis. So the decision for Cappuccino Pharmaceuticals to proceed might never have happened.”

Rupert put his head on the table and moaned. “So we wasted millions of dollars chasing rainbows again? Can’t we ever do real experiments that work?” He sat up and announced, “I’m revising my plan. Maybe we should drop out of therapeutics and move into medical devices. I read about this stomach sucker patent [3] and I figure the next step is a brain sucker.”

“Is that a lollipop for zombies?” Ima Punk asked.

“Very funny,” Rupert said with no hint of a smile. “This is serious.” He waggled his fingers over his tablet, then showed the glowing surface to the Board members. “It says here the original patent might be a treatment for morbid obesity without invasive surgery. Patients can eat and drink as much as they like. Twenty minutes later, they drain their stomach by connecting a pump to a valve surgically installed on their abdominal wall.”

“That might destroy the game of beer pong,” the CFO said. “But besides losing our appetites, what are you proposing here?”

“Well, so the logical next step is to attach a brain pump. Then 20 minutes after watching TV, you can get all the crap sucked back out. Or, if you’re watching Factsless News, leave the pump running.”

“Helicopters, dear?” Maybelle looked up from the poker game playing out on her ComputTablet. “Not that irate ex-boyfriend of Vivian’s again, is it?”

Maybelle sat up sharply. “Masterminding? What happened?”

Rupert lifted his SmarterNUphone. “I just got a report that they hit our warehouse last night. This would send me through the roof, but the thieves already did that. Over $80 million worth of our drugs stolen.”

Maybelle gasped “Eighty million? Oh, Rupert, are we ruined?”

Rupert smiled. “Actually, it might help. They stole all our CantaDaptive has been approved in seventy countries already, including in Europe, but not FDA approved. A clinical trial just found it failed to reduce major vascular events. So the FDA and the European Medicine Agency recommended we pull it off the market.”

“How did it ever get approved in those 70 countries?”

“Never mind!” Rupert said. “Anyway. So now it’s effectively pulled for us and we get the insurance money. It’s like a mix of Merck and Eli Lilly.”

“Lilly? Wasn’t that a theft done by a gang of Cubans?”

“Yes, but how did they get their information?” Rupert asked. “It may be connected with the report from FQNA-DT Security. If data got leaked, they are now FQNA-BooBoo Security.”

Maybelle’s tablet pinged, and she bent her head to read an incoming message. “I see bank robberies in the San Gabriel Valley are from rooftop break-ins. Do you think they’re related?”

“Yes, it must be,” Rupert said. “Our warehouse is out there. Maybe the banks were a way of practicing after the Cuban gang was picked up. And I think the tubas were practice before that.”

“Tubas?” Maybelle looked bewildered. “What do tubas have to do with drugs?”

“Security!” Rupert waggled a finger. “Remember that rash of tuba thefts from LA area high schools some time ago? Training runs. All of these required sophisticated knowledge of security systems. Surveillance by helicopter might help. And swatting the cops away.”

“Swatting?” Maybelle looked angrily at Rupert. “I know you want to appear witty and in the know. But swatting cops?”

“It’s a quaint local custom of calling 911 to say some horrible crime is happening at some celebrity’s mansion. All the SWAT teams rush off to rescue the would-be victim. It’s been a prank, but how long until a real crime is planned at the same time?”

“Like your warehouse. What celebrities live near the warehouse?”

“El Monte?” Rupert pounded his temples with his fists. “Think, Rupert! Who lives in-” He looked up with a gasp. “Vivian.”

Suddenly, policemen boiled over the compound fence from all directions. A voice pierced the warm afternoon breeze. “Halt! Are you the Madashecks? Are you alright?” They heard the faint thrum of an approaching helicopter.

“I’m worried about my mortality,” Rupert Madasheck said with a moan. He looked down at his feet. “Ever since the biotech world started banging on our door about that penis size study, [1] I can’t tell if it’s the beginning or the end.”

“Well, Cappuccino Pharmaceuticals is part of PNAS Productions after the reverse merger,” George Contenumbaes pointed out. [2] “It’s only natural some reporters would call us instead of PNAS the science journal.”

Rupert held his phone over his arm for a second, then held it over his cheek. Betty tapped her pen on the conference table and asked, “Rupert, what are you doing now? If you are cracking up, then we need to start searching for a new CEO.”

Rupert put his phone down and said, “I’m checking for skin cancer. I don’t want to be surprised as I get older.”

Betty looked at George and raised her eyebrows. George said, “It’s called teledermatology. An app will analyze skin lesions and figure out if any are cancerous.”

Betty swiveled to face a new face in the room. “You must be Mantissa Polatis, our newest VP of Research. What do you know about this?”

Mantissa turned white as a sheet. “I…that is…those don’t work very well. But the phone is always right there in your hand, so no one can resist checking.”

Betty narrowed her eyes. “Why are you so pale? Are you afraid of saying something wrong?”

Mantissa began to shiver. “Well, yes, I’m the third VP of Research this month and…” She ceased talking and eyed the door.

Betty rolled back in her chair and laughed. “It’s not as if we dumped people in the street every day. We are not like Mylan, you know.”

“Or like Alkermes,” Rupert said.

“It’s OK, Mantissa, you can tell them. Or maybe I should,” Rupert said. He turned to address the Board of Directors. “I asked Dr. Polatis to the Board meeting to tell us what’s the latest buzz. So to speak.”

“There was a study on the health benefits of a vibrating platform for geriatric patients,” Mantissa said. [3] “Dr. Madasheck wanted to know if we should have a platform installed in the company’s fitness room.”

“Doctor?” Betty asked. “If Rupert is a doctor, then I’m the Queen of Mars.”

“Fitness room?” George asked. “We have a fitness room?”

“It seems the best solution is to replace office chairs with vibrating seats,” Mantissa said. “The study was inconclusive, no one in the entire company uses the fitness room, and Dr. – Mr. Madasheck said he’d rather have a vibrating seat.”

Rupert heard hoots of laughter from the boardroom as he approached from his office. As he entered, Betty said, “Of course it matters, we all know that.” The others gathered around the table laughed.

Rupert said, “Ms. Lidalot, as Chair of this corporation, you should display a much more sober attitude before the Board.”

“Well, that’s about the size of it,” said CFO George Contenumbaes. The others, including Betty, snickered and stifled giggles.

“Something is going on here,” Rupert said. “Why is it the CEO is always the last to know? So let’s hear it.”

Felicity Short, the Director from LotzMooreLute Capital, pushed a journal down the table and said, “It looks like that stuffy old National Academy of Sciences has people with a sense of humor after all. Check out the bookmarked page.”

Rupert found the page, scanned the large-print title, and gasped. It read, ‘Penis size interacts with body shape and height to influence male attractiveness.’ [1]

Betty said, “The National Academy is a very serious organization, charged with providing scientific leadership for the country. The Proceedings of the National Academy of Sciences is a serious and prestigious journal. But their website does exhort you to add ‘PNAS Direct to Your Inbox.’ Doesn’t that sound a bit rude?”

“Well, there must be a potent evolutionary motivation at work,” said Ima Punk.

“What does any of this have to do with biotechnology?” Rupert asked. “Must we behave like middle schoolers?”

“We must understand the wants and needs of our customers,” said Betty.

“What you are telling me is that X-ray specs actually work,” said Rupert.

“Well, yes, if you put it that way. Light does pass into and out of the body,” said the young woman with the large Visitor badge. “Our company has followed up research from the Imperial College in London, which monitored the path of bacterial infection by scanning patients in the dark.”

“To be precise,” her older gentleman companion said, “the patients were mice infected with a light-generating bacterium. We intend to use human patients.”

“And you claim you can watch this infection in 3D and in real time,” Rupert said.

“Yes,” both visitors said.

The gentleman said, “What we propose here, Mr. Madasheck, is a partnership where we provide the way for you to monitor your clinical trials by literally watching how your drug works.”

“I can adapt this system to any infection you plan to treat,” the woman said. “The patient must stay in a completely dark chamber during the scan. But I assure you, bacteria emit enough light that passes through the body and you can make videos of it. I have also followed up earlier work that used natural bacteria in yogurt.”

“Now we can study what happens when you treat drug-resistant superbugs,” the gentleman said. “We believe Cappuccino Pharmaceuticals can make amazing breakthroughs when it no longer needs to guess what is happening.”

Rupert pondered the proposition and looked back and forth from one visitor to the other. Finally, he said, “Amazing. We of course would own the film rights, yes?”

**** **** ****

Meanwhile, Betty Lidalot strolled through the third floor clothing collections of Bergdorf Goodman when she recognized the pregnant supermodel Kim Kevorkian surrounded by a posse of handlers. Kim sported what looked like a pair of headlights strapped to her belly with the beams of light pointing inwards. Unable to resist, Betty introduced herself and asked, “Can you tell me about this device? I’ve never seen anything like it, at least not strapped so low.”

Kim grinned and patted the headlights affectionately. “You remember back when women wore headphones on their bellies to pipe in Mozart and make their children into geniuses? Well, now we beam light into them.”

One of Kim’s handlers stepped forward to block Betty’s approach and said, “Ma’am, Ms. Kevorkian keeps up to date with research that body-penetrating light helps the eyes develop. Fact.”

Betty stepped back and stared at him. “Fact? Where was this ‘research’ done?”

“UC San Francisco and Cincinnati Children’s Hospital, ma’am,” said the handler. “We might prevent eye diseases by making sure women get plenty of direct light. That activates some protein called melanopsin. But you want the right kind of light, not just flashing glitter.”

“I’m designing my own line of lamps so you can light up your baby’s life,” Kim said as her retinue moved on.

Betty Lidalot considers the idea of stiletto surgery:

“There must be a better way to wear heels like those. I’m not quite a ballerina, so I can’t stand on just my toes.”

Carla DuCansa looked up from trying on a pair of Nicholas Kirkwood black satin pumps with 5” heels and crystal platforms. “You had any bunions removed already?”

“Of course,” said Betty. “That was the obvious first step. The biomedical industry should be able to put its vast resources on to this problem.

Carla waved a hand vaguely. “Oh, long ago. First there was the collagen injection into the ball of your foot.” She lifted up her leg and pointed to it. “I had that done ages ago. Now it’s like I’m walking around on pillows.”

Betty closed her eyes dreamily. “That sounds wonderful. Is that why you wear those stilt heels all day every day?”

“Oh, no, there is more to it. I needed to have my toes shortened.”

Betty’s eyes flew open. “You shortened your toes? Why?”

“It’s not as if the shoe industry did us any favors,” Carla said. “They still refuse to design a single comfortable shoe, or one that fits. So I needed to make my foot fit the shoe. Who needs a lifetime of pinched nerves?” She stood up and pirouetted on the toe of one shoe.

“Amazing,” Betty breathed. “You look as though you could fly. Is it worth the surgery?”

“Not yet,” Carla said as she descended from the heights of her heels. “Not until I did Deep Pink.”

“Toenail polish?” Betty guessed.

“My favorite shoes,” Betty said. “To look at, anyway. I can’t imagine how you wear them all day. So you think the Deep Pink surgery was worth it?”

“I’ve never felt this good about any surgery I’ve ever had done. If it’s vain, it’s vain. But…” Carla looked at the shoes on her feet. “They seem to stop at five and a half inch heels. Anything taller, and they add a platform. Why can’t I get a good seven inch heel – or no heel at all. There is a clinic that will fuse your ankle and remove all those ugly toes. Then you can tiptoe around as the most elegant ballerina you ever saw. Add a platform box toe, and you can tower anyone in the room.”

Carla pirouetted on the heel of her right shoe, then on the toe of her left shoe. “And it’s a market opportunity.” She coasted to a halt, then sat down daintily.

“What’s the opportunity?” asked Betty.

“My dear, we make medical devices,” said Carla. “You know, like wheelchairs and walkers. As we all age, we will need something more fashionable than Granny’s towel rack. As these foot surgeries become more popular, we must prepare an equally fashionable walker. And I, my dear, will be ready.”

“Is this about the new TV show you mentioned?”

“Yes, we take away Granny’s towel rack with its hideous and tacky tennis balls on the feet. We trick it out into something you can be proud of.”

“What’s the name of the show?” Betty asked, not sure if she wanted the answer.